BLUE BELL, Pa., June 10, 2014 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) today announced it has initiated a phase I/IIa clinical trial to evaluate safety, immunogenicity and clinical responses of its immunotherapy product, INO-3112, in treating human papillomavirus (HPV)- associated head and neck cancer. INO-3112 is a combination of Inovio's lead active immunotherapy product, VGX-3100, and its proprietary immune activator expressing interleukin-12 (IL-12). VGX-3100 is currently being evaluated in a randomized phase II efficacy trial for the treatment of high grade cervical dysplasia (pre-cancer).

In a phase I trial of VGX-3100, Inovio demonstrated that this immunotherapy produced high levels of durable T cell immune responses, notably CD8+ "killer" T cells, in 78% of all patients in the study. These CD8+ T cells showed the functional ability to kill target cells displaying the E6 and E7 antigens. In preclinical animal models, Inovio's HPV immunotherapy demonstrated 100% protection against HPV E6 and E7-expressing tumors and prevented or delayed the growth of such tumors. The proprietary IL-12 immune activator, INO-9012, was previously shown to enhance antigen-specific CD4+ and CD8+ T cell immune responses to Inovio's PENNVAX® HIV DNA vaccine in a clinical trial. Inclusion of this DNA-based immune activator in INO-3112 is designed to increase the generation of HPV-specific CD8+ T cells for the treatment of HPV-related cancer.

In this open-label study, called HPV-005, up to twenty adults with HPV-positive head and neck squamous cell carcinoma (HNSCC) will be treated with INO-3112 and followed for safety, immune and clinical responses. In one part of the study, up to ten patients will be treated with INO-3112 before and after resection of their tumor. In the second part of the study, up to ten patients will be treated with INO-3112 after completion of chemotherapy and radiation therapy. Each INO-3112 treatment will be administered using Inovio's CELLECTRA® delivery system.

In addition to assessing safety, this study will analyze T cell immune responses to INO-3112. Pre- and post-immunotherapy tumor tissue will be analyzed to evaluate infiltration of T cells into the tumor and tumor bed. Clinical responses characterized by anti-tumor effects, using RECIST criteria, and progression free survival will also be measured.

The study will be conducted at the Abramson Cancer Center (ACC) in the Perelman School of Medicine (PSOM) at the University of Pennsylvania, one of the world's premier cancer treatment center, and led by principal investigator Charu Aggarwal, MD, MPH, assistant professor of medicine in the division of hematology-oncology at the PSOM and ACC.

Dr. J. Joseph Kim, Inovio's President and CEO, said, "Initiating this head and neck cancer study is just the tip of the iceberg in our oncology immune therapy development plans. Onco-immunotherapy is all about T cells the very thing which our products have been shown to stimulate extremely well. We look forward to our upcoming unblinded cervical dysplasia phase II study data on efficacy and T cell responses this summer."

"We will also launch additional cancer clinical studies to further characterize and expand the potential of our DNA immune therapy products and immune activators with their potent abilities to generate and activate the highest levels of antigen-specific killer T cells. These include trials for INO-5150 for prostate cancer with our pharmaceutical partner in Q3 and INO-1400, our immunotherapy encoded for hTERT in breast, lung and pancreatic cancer patients later this year. Our goal is to have the best and most extensive pipeline of active cancer immunotherapies with the potential to seek out and destroy cancer cells," said Dr. Kim.

Human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, infecting 79 million Americans. HPV infection may lead to cervical dysplasia and cancer as well as cancers of the anogenital tract. HPV-caused head and neck cancer is the fastest growing cancer in men and is expected to overtake the incidence of HPV-caused cervical cancers by the end of this decade. If proven effective, INO-3112 could augment current therapeutic approaches to head and neck cancer. Today's therapy for oropharyngeal (head & neck) cancer is a combination of chemotherapy, radiation and surgical resection. The treatments have many potential side effects, including damage to the throat, which can hinder the ability to speak and swallow.

VGX-3100 and INO-3112 for Treating HPV-Caused Diseases

Inovio's lead product, VGX-3100, is a DNA-based immunotherapy for precancers and cancers caused by HPV. This product, without an immune activator, is currently in a randomized, double-blind phase II trial evaluating its efficacy and immune responses against HPV-caused cervical dysplasia. INO-3112 combines this immunotherapy with a DNA-based IL-12 immune activator to further boost the targeted immune response against head and neck cancer, cervical cancer and other cancers.

Inovio's Immune Activators

Immune activators can play a vital role in augmenting antigen-specific immune responses such as those generated by Inovio's DNA vaccines. Inovio's portfolio of patent-protected, DNA-based immune boosters vary in their ability to activate and enhance therapeutic T cells or preventive antibodies, modulate the type of immune responses produced by the vaccine, impact durability of immune responses, and drive immune responses to sites of infection, e.g. mucosal surfaces. Different immune activators can therefore play unique roles in achieving desired immune responses generated by DNA immunotherapies and vaccines. Moreover, while some protein-based cytokines and chemokines have been shown to have severe toxicity, likely due to their dosing levels and systemic delivery, Inovio's DNA-based immune activators and immunotherapeutics are delivered together at one injection site with the goal of enabling local production by the body of cytokines or chemokines, along with antigens that drive immune responses with disease modifying benefits and no toxic systemic effects.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines, in combination with its proprietary electroporation delivery, are generating best-in-class immune responses, with therapeutic T-cell responses exceeding other technologies in terms of magnitude, breadth, and response rate. Human data to date have shown a favorable safety profile. Inovio's lead vaccine, a therapeutic against HPV-caused pre-cancers and cancers, is in phase II. Other phase I and preclinical programs target prostate, breast, and lung cancers as well as HIV, influenza, malaria and hepatitis. Partners and collaborators include Roche, the University of Pennsylvania, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, US Dept. of Homeland Security, and University of Manitoba. More information is available at www.inovio.com.

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2013, our Form 10-Q for the quarter ended March 31, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.